Bone tie and bone tie inserter

ABSTRACT

Various embodiments of bone ties, bone tie inserters, and methods for treating the spine are provided. The bone tie can include a proximal end and a distal end. The bone tie can include a head section comprising a rounded head. The bone tie can include a neck section extending proximally from the head section. A bone tie inserter for placing a bone tie can also be provided. The bone tie inserter can include a bone tie advancer with a curved surface configured to guide a rounded head of a bone tie. The bone tie inserter can include a bone tie retriever configured to receive the rounded head of a bone tie. The bone tie is configured to pivot and/or rotate within the retriever portion of the bone tie inserter. The method can include forming a lumen in a first bone portion and a second bone portion. The bone tie can be configured to pivot and/or rotate as the bone tie retriever is withdrawn.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 16/751,883, filed Jan. 24, 2020, which claims priority benefitto U.S. Provisional Patent Application No. 62/851,410, filed May 22,2019, the entirety of which is hereby incorporated by reference herein.

BACKGROUND Field

Some embodiments described herein relate generally to systems andmethods for performing spinal fusion and, in particular, to bone tiesand bone tie inserters.

Description of the Related Art

Traumatic, inflammatory, and degenerative disorders of the spine canlead to severe pain and loss of mobility. According to some studies,back and spinal musculoskeletal impairments are the leading causes oflost work productivity in the United States. Pain as a result of sometype of spinal impairment may have its source in a variety ofpathologies or clinical conditions.

One source for back and spine pain is related to degeneration of thefacets of the spine or facet arthritis. Bony contact or grinding ofdegenerated facet joint surfaces may play a role in some pain syndromes.While many technological advances have focused on the spinal disc andartificial replacement or repair of the disc, little advancement infacet repair has been made. Facet joint and disc degeneration frequentlyoccur together. Thus, there is a need to address the clinical concernsraised by degenerative facet joints.

The current standard of care to address the degenerative problems withthe facet joints is to fuse the two adjacent vertebrae together. Byperforming this surgical procedure, the relative motion between the twoadjacent vertebrae is stopped, thus stopping motion of the facets andany potential pain generated as a result thereof. This surgicalprocedure has a high rate of morbidity and can potentially lead tofurther clinical complications such as adjacent segment disorders. Thisprocedure is also not reversible. Therefore, if the patient has anunsatisfactory result, they may be subject to additional surgical fusionprocedures.

SUMMARY

Devices and methods are disclosed for treating the vertebral column. Insome embodiments, a bone tie for securing or fusing facets is provided.In some embodiments, a bone tie inserter is provided. In someembodiments, a method of use to treat the spine is provided.

In some embodiments, a bone tie for treating the spine is provided. Thebone tie can include a proximal end and a distal end. The bone tie caninclude a head section comprising a rounded head. The bone tie caninclude a neck section extending proximally from the head section.

In some embodiments, the bone tie can include a body section extendingproximally from the neck section, wherein the body section comprises oneor more gears. In some embodiments, the bone tie can include a fastenersection, wherein the fastener section comprises a ratchet. In someembodiments, the bone tie can include a body section extendingproximally from the neck section, wherein the body section comprises agroove. In some embodiments, the head section comprises a flange. Insome embodiments, the head section comprises a radiopaque marker.

In some embodiments, a bone tie inserter for placing a bone tie fortreating the spine is provided. The bone tie inserter can include a bonetie advancer. The bone tie advancer can include a shaft. The bone tieadvancer can include an advancer portion comprising a curved surfaceconfigured to guide a rounded head of a bone tie. The bone tie insertercan include a bone tie retriever. The bone tie retriever can include ashaft. The bone tie retriever can include a retriever portion configuredto receive the rounded head. In some embodiments, the rounded head ofthe bone tie is configured to pivot and/or rotate within the retrieverportion.

In some embodiments, the bone tie inserter can include the bone tie. Insome embodiments, the advancer portion comprises a curve. In someembodiments, the retriever portion comprises a ledge. In someembodiments, the retriever portion comprises a channel. In someembodiments, the retriever portion is configured to receive the roundedhead of a bone tie. In some embodiments, the advancer portion comprisesa channel configured to receive a neck section extending proximally fromthe rounded head.

In some embodiments, a method of treating bone portions is provided. Themethod can include forming a lumen in a first bone portion. The methodcan include forming a lumen in a second bone portion. The method caninclude advancing a rounded head of a bone tie with a bone tie advancerthrough the lumen of the first bone portion and into the lumen of thesecond bone portion. In some embodiments, the bone tie advancer isremovably coupled to the rounded head or a neck section extending fromthe rounded head. The method can include advancing the rounded head ofthe bone tie into a retriever portion of a bone tie retriever. In someembodiments, the retriever portion comprises a channel to receive therounded head. The method can include withdrawing the bone tie retrieverfrom the second bone portion, wherein the bone tie is configured topivot and/or rotate as the bone tie retriever is withdrawn.

In some embodiments, the bone tie advancer comprises a channel toreceive the neck section of the bone tie. In some embodiments, the bonetie advancer comprises a curve. In some embodiments, the bone tieadvancer comprises a rounded section to abut the rounded head of thebone tie. In some embodiments, the bone tie retriever comprises anopening, wherein the neck section pivots, or pivots and rotates, fromextending from the channel to extending through the opening. In someembodiments, the bone tie retriever comprises one or more retentionfeatures configured to retain the bone tie. In some embodiments, thebone tie retriever comprises a ledge. In some embodiments, the ledgefacilitates pivoting and/or rotating of the rounded head of the bonetie.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of use will be better understood with thefollowing detailed description of embodiments, along with theaccompanying illustrations, in which:

FIG. 1 is a perspective front view of an embodiment of a bone tie.

FIG. 2 is a perspective back view of the bone tie of FIG. 1.

FIG. 3 is a perspective view of a proximal portion of the bone tie ofFIG. 1.

FIG. 4 is a perspective view of a distal portion of the bone tie of FIG.1.

FIG. 5 is an enlarged perspective view of a distal portion of the bonetie of FIG. 1.

FIG. 6 is a perspective front view of an embodiment of a bone tieadvancer.

FIG. 7 is a perspective front view of a distal portion of the bone tieadvancer of FIG. 6.

FIG. 8 is a perspective back view of a distal portion of the bone tieadvancer of FIG. 6.

FIG. 9 is a perspective front view of an embodiment of a bone tieretriever.

FIG. 10 is a perspective front view of a distal portion of the bone tieretriever of FIG. 9.

FIG. 11 is a front view of a distal portion of the bone tie retriever ofFIG. 9.

FIG. 12 is a cross-sectional view of the distal portion of the bone tieretriever of FIG. 9.

FIG. 13 is a cross-sectional view of the distal portion of the bone tieretriever of FIG. 9.

FIG. 14 is a view of the bone tie of FIG. 1, the bone tie advancer ofFIG. 6, and the bone tie retriever of FIG. 9 within the vertebrae.

FIG. 15 is an enlarged view of FIG. 14.

FIG. 16 is a cross-sectional view of the bone tie of FIG. 1 and the bonetie retriever of FIG. 9 within the vertebrae.

FIG. 17 is a side view of the bone tie of FIG. 1, the bone tie advancerof FIG. 6, and the bone tie retriever of FIG. 9.

FIG. 18 is a perspective view of the bone tie of FIG. 1, the bone tieadvancer of FIG. 6, and the bone tie retriever of FIG. 9.

FIG. 19 is a perspective view of the bone tie of FIG. 1 and the bone tieretriever of FIG. 9.

FIG. 20 is a perspective view of the bone tie of FIG. 1 and the bone tieretriever of FIG. 9.

FIG. 21 is a distal view of the bone tie of FIG. 1 and the bone tieretriever of FIG. 9.

FIG. 22 is a perspective view of an embodiment of a bone tie retriever.

FIG. 23 is a perspective view of a distal portion of the bone tieretriever of FIG. 22.

FIG. 24 is a front view of a distal portion of the bone tie retriever ofFIG. 22.

FIG. 25 is another front view of a distal portion of the bone tieretriever of FIG. 22.

FIG. 26 is a cross-sectional view of the distal portion of the bone tieretriever of FIG. 22.

FIG. 27 is a cross-sectional view of the distal portion of the bone tieretriever of FIG. 22.

DETAILED DESCRIPTION

Although certain preferred embodiments and examples are disclosed below,it will be understood by those in the art that the disclosure extendsbeyond the specifically disclosed embodiments and/or uses of theinvention and obvious modifications and equivalents thereof. Thus, it isintended that the scope should not be limited by the particulardisclosed embodiments described below.

The systems and methods described herein relate to embodiments of boneties, embodiments of bone ties inserters, and methods of use. The bonetie inserter can facilitate insertion of bone tie, as described herein.The bone tie can be inserted within a bone lumen, such as a bone lumenbetween adjacent vertebrae. The bone tie can be advanced by a bone tieadvancer. The bone tie can be received by a bone tie retriever. In someembodiments, the bone tie pivots and/or rotates as the bone tie iswithdrawn from the bone lumen between adjacent vertebrae.

1. Anatomy of the Spine

The vertebral column comprises a series of alternating vertebrae andfibrous discs that provide axial support and movement to the upperportions of the body. The vertebral column typically comprisesthirty-three vertebrae, with seven cervical (C1-C7), twelve thoracic(T1-T12), five lumbar (L1-L5), five fused sacral (S1-S5) and four fusedcoccygeal vertebrae. Each typical thoracic vertebra includes an anteriorbody with a posterior arch. The posterior arch comprises two pediclesand two laminae that join posteriorly to form a spinous process.Projecting from each side of the posterior arch is a transverse,superior and inferior articular process. The facets of the superior andinferior articular processes form facet joints with the articularprocesses of the adjacent vertebrae. The facet joints are true synovialjoints with cartilaginous surfaces and a joint capsule.

The orientation of the facet joints vary, depending on the level of thevertebral column. In the C1 and C2 vertebrae, the facet joints areparallel to the transverse plane. In the C3 to C7 vertebrae, the facetsare oriented at a 45 degree angle to the transverse plane and parallelto the frontal plane, respectively. This orientation allows the facetjoints of the cervical vertebrae to flex, extend, lateral flex androtate. At a 45 degree angle in the transverse plane, the facet jointsof the cervical spine can guide, but do not limit, the movement of thecervical vertebrae. For the thoracic vertebrae, the facets are orientedat a 60 degree angle to the transverse plane and a 20 degree angle tothe frontal plane, respectively. This orientation is capable ofproviding lateral flexion and rotation, but only limited flexion andextension. For the lumbar region, the facet joints are oriented at 90degree angles to the transverse plane and a 45 degree angle to thefrontal plane, respectively. The lumbar vertebrae are capable offlexion, extension and lateral flexion, but little, if any, rotationbecause of the 90 degree orientation of the facet joints in thetransverse plane. The actual range of motion along the vertebral columncan vary considerably with each individual vertebra.

In addition to guiding movement of the vertebrae, the facet joints alsocontribute to the load-bearing ability of the vertebral column. Onestudy by King et al. Mechanism of Spinal Injury Due to CaudocephaladAcceleration, Orthop. Clin. North Am., 6:19 1975, found facet jointload-bearing as high as 30% in some positions of the vertebral column.The facet joints may also play a role in resisting shear stressesbetween the vertebrae. Over time, these forces acting on the facetjoints can cause degeneration and arthritis.

2. Bone Tie

FIGS. 1-5 depict views of an embodiment of a bone tie 100. FIG. 1illustrates a perspective front view. FIG. 2 illustrates a perspectiveback view. FIG. 3 illustrates a perspective view of a proximal portionof the bone tie 100. FIG. 4 illustrates a perspective view of a distalportion of the bone tie 100. FIG. 5 illustrates an enlarged perspectiveview of a distal portion of the bone tie 100.

The bone tie 100 can be a generally elongate member. The bone tie 100can comprise a proximal end 102 and a distal end 104. The bone tie 100can include a length between the proximal end 102 and the distal end104. The proximal end 102 can be configured to be near the hands of theuser when the user is manipulating the bone tie inserter as describedherein. The distal end 104 can be configured to be inserted into a bonelumen as described herein. The distal end 104 can be configured to bethe first portion of the bone tie 100 that is inserted in the lumen. Thedistal end 104 can be the leading end of the bone tie 100. In somemethods of use, the proximal end 102 extends away from the vertebraeduring insertion of the bone tie 100. In some methods of use, theproximal end 102 is held by the user. In some methods of use, theproximal end 102 is unconstrained during insertion of the bone tie 100.In some methods of use, only a portion of the bone tie 100 near thedistal end 104 is grasped and manipulated by the bone tie inserter asdescribed herein. In some methods of use, a portion of the bone tie 100near the proximal end 102 is retained along the bone tie inserter.

The bone tie 100 can include one or more sections along the length ofthe bone tie 100. The sections can have a different shape,configuration, or function than an adjacent section of the bone tie 100.In some embodiments, one or more non-adjacent sections can have the sameshape, configuration, or function as another section of the bone tie100. In some embodiments, one or more additional sections are provided.In some embodiments, one or more of the sections provided herein areomitted.

The bone tie 100 can include a fastener section 106. The fastenersection 106 can be located at or near the proximal end 102. The fastenersection 106 can include any mechanism configured to secure the fastenersection 106 to another section of the bone tie 100. The fastener section106 can include a mechanism that allows the bone tie 100 to be securedin a single direction of travel such as a ratchet. The fastener section106 can include a mechanism that allows the bone tie 100 to be securedin two directions of travel such as a pair of gears.

The bone tie 100 can include a first section 108. The first section 108can be closer to the proximal end 102 than the distal end 104. The firstsection 108 can have a first cross-sectional shape. The first section108 can extend distally from the fastener section 106. The bone tie 100can include a second section 110. The second section 110 can be closerto the proximal end 102 than the distal end 104. The second section 110can have a second cross-sectional shape. The second section 110 canextend distally from the first section 108. The bone tie 100 can includea third section 112. The third section 112 can be closer to the distalend 104 than the proximal end 102. The third section 112 can have athird cross-sectional shape. The third section 112 can extend distallyfrom the second section 110.

The bone tie 100 can include a neck section 114. The neck section 114can be closer to the distal end 104 than the proximal end 102. The necksection 114 can taper from the third section 112 toward the distal end104. The neck section 114 can extend distally from the third section112. The neck section 114 can facilitate manipulation of the distalportion of the bone tie 100 by the bone tie inserter, as describedherein. The neck section 114 can be shaped to interface with the bonetie inserter. The neck section 114 can be shaped to form a mechanicalinterfit or coupling as described herein.

The bone tie 100 can include a head section 116. The head section 116can be located at or near the distal end 104. The neck section 114 cantaper toward the head section 116. The head section 116 can extenddistally from the neck section 114. The head section 116 can facilitatemanipulation of the distal portion of the bone tie 100 by the bone tieinserter, as described herein. The head section 116 can be shaped to begrasped or cupped by the bone tie inserter. The head section 116 can beshaped to pivot and/or rotate relative to the bone tie inserter.

FIG. 2 is a perspective back view of the bone tie 100. The bone tie 100can have a smooth surface along the first section 108, the secondsection 110, and the third section 112. The bone tie 100 can have acontinuous surface along the first section 108, the second section 110,and the third section 112.

FIG. 3 illustrates a perspective view of a proximal portion of the bonetie 100. The bone tie can include the proximal end 102, the fastenersection 106, first section 108, and the second section 110.

The fastener section 106 can include a lumen 118. The lumen 118 can beoriented perpendicular to a longitudinal axis 150 of the bone tie 100.The bone tie 100 can include a ratchet 122 disposed within the lumen118. The ratchet 122 is configured to deflect to allow one or gears totravel through the lumen 118 in one direction, but limit or preventtravel in another direction. The fastener section 106 can form anenlarged end of the bone tie 100. The fastener section 106 can begenerally rectangular or cuboid. The fastener section 106 can have awidth larger than the first section 108. The fastener section 106 canhave a thickness larger than the first section 108. The fastener section106 can include rounded edges or corners. The fastener section 106 canhave any shape to accommodate the ratchet 122 disposed therewithin. Thefastener section 106 can have any shape to accommodate any fastenermechanism described herein.

The first section 108 can have the first cross-sectional shape. Thefirst cross-sectional shape can be generally rectangular or cuboid. Thefirst cross-sectional shape can have rounded edges or corners. The firstsection 108 can include a width and a thickness. The first section 108can include a groove 124. The groove 124 can reduce the thickness of thefirst section 108. The groove 124 can taper from the fastener section106. The groove 124 can taper to the second section 110.

The second section 110 can have the second cross-sectional shape. Thesecond cross-sectional shape can be generally rectangular or cuboid. Thesecond cross-sectional shape can have rounded edges or corners. Thesecond section 110 can include a groove 126. The groove 124 of the firstsection 108 can extend to the groove 126 of the second section 110. Thesecond section 110 can include one or more gears 128. The gears 128 canbe ramped surfaces. The gears 128 can form a rack. The gears 128 can bewedge surfaces. The gears 128 can be inclined upward toward the proximalend 102. The gears 128 can be inclined downward toward the distal end104. The gears 128 can be disposed within the groove 126 of the secondsection 110. The first section 108 and the second section 110 caninclude a constant width. The first section 108 and the second section110 can include a constant thickness. The first section 108 and thesecond section 110 can include a constant thickness measured along theedges of the first section 108 and the second section 110.

FIG. 4 illustrates a perspective view of a distal portion of the bonetie 100. The bone tie can include the second section 110, the thirdsection 112, the neck section 114, the head section 116, and the distalend 104.

The third section 112 can have a third cross-sectional shape. The thirdcross-sectional shape can be generally rectangular or cuboid. The thirdcross-sectional shape can have rounded edges or corners. In someembodiments, the first cross-sectional shape and the thirdcross-sectional shape are the same or similar. The third section 112 caninclude a width and a thickness. The third section 112 can include agroove 130. The groove 130 can reduce the thickness of the third section112. The groove 130 can taper from the second section 110. The groove130 can taper to the neck section 114.

Two or more of the first section 108, the second section 110, and thethird section 112 can include a constant width. Two or more of the firstsection 108, the second section 110, and the third section 112 caninclude a constant thickness. Two or more of the first section 108, thesecond section 110, and the third section 112 can include a constantthickness measured along the edges of the respective sections. The bonetie 100 can have a constant width along a substantial portion of thelength. The bone tie 100 can have a constant thickness along asubstantial portion of the length.

FIG. 5 illustrates an enlarged view of the distal portion of the bonetie 100. The bone tie 100 can include the neck section 114. The necksection 114 tapers along the width. The neck section 114 tapers from alarger width near the third section 112 to a smaller width near the headsection 116. The neck section 114 can include a groove 132. The groove132 can reduce the thickness of the neck section 114. The groove 132 ofthe neck section 114 can extend from the groove 130 of the third section112.

The neck section 114 can lie in a plane along the longitudinal axis 150of the bone tie 100 or the neck section 114 can include a curve 134. Thecurve 134 can have a constant radius of curvature. Two or more of thefirst section 108, the second section 110, and the third section 112 canbe planar. The bone tie 100 can lie in a plane along a substantialportion of the length. The curve 134 can extend from the plane of thebone tie. The curve 134 can extend upward from the grooves 124, 126,130, 132 of the bone tie 100. The curve 134 can extend upward from thegears 128 of the second section 110. The curve 134 can extend away fromthe longitudinal axis 150 of the bone tie 100.

The bone tie 100 can include the head section 116. The head section 116can include a head 136. The head 136 can be rounded. The head 136 can bespherical. The head 136 can extend to the distal end 104 of the bone tie100. The head section 116 can include a flange 138. The flange 138 canbe positioned on the head 136. The flange 138 can be a rounded bill thatextends from the head 136. The flange 138 can include a first taperedsurface 140 and a second tapered surface 142. The first tapered surface140 and the second tapered surface 142 can have different slopes. Thesecond tapered surface 142 can form a ledge by which the head section116 or head 136 can be grasped. The first tapered surface 140 and thesecond tapered surface 142 extend to the neck section 114.

The bone tie 100 can include a marker 144. The marker 144 can facilitatevisualization of the bone tie 100, or a portion thereof. In theillustrated embodiment, the head 136 can include the marker 144. Thehead 136 can include a bore 146. The bore 146 can extend from an edge ofthe head 136 inward toward or past the center of the head 136. Themarker 144 can be disposed within the bore 146. The marker 144 can be aradiopaque marker. The marker 144 can be formed of a metal or otherradiopaque material. The marker 144 can identify the distal end 104 ofthe bone tie 100. In some embodiments, the bone tie 100 comprises anon-radiopaque material. In some embodiments, one or more radiopaquemarkers may be embedded in or on the bone tie 100 to assist in placementor monitoring of the bone tie 100 under radiographic visualization.

The bone tie 100 can be a flexible fastening band. The bone tie 100 caninclude the proximal end portion 102 and the distal end portion 104. Insome embodiments, the head section 116 can be removed. The neck section114 can be advanced through the lumen 118. When the neck section 114 isadvanced, the ratchet 122 can extend into the groove 132. The thirdsection 112 can be advanced through the lumen 118. When the thirdsection 112 is advanced, the ratchet 122 can extend into the groove 130.The second section 110 can be advanced through the lumen 118. When thesecond section 110 is advanced, the ratchet 122 can extend into thegroove 126. The ratchet 122 can engage the gears 128. The ratchet 122can allow the second section 110 to travel through the lumen 118 in onedirection, but limit travel through the lumen 118 in the oppositedirection.

The bone tie 100 can be configured for altering the motion at the facetjoints of the vertebral column. In some embodiments, the bone tie 100can prevent motion of the facet joint. In some embodiments, the bone tie100 can limit or reduce motion of the facet joint. In some embodiments,the bone tie 100 can limit motion to a range depending on the tighteningof the loop of the bone tie 100. In some methods of use, the bone tiepromotes fusion of the facet joints.

The bone tie 100 can be configured for altering the spacing at the facetjoints of the vertebral column. In some embodiments, the bone tie 100can reduce the spacing. In some embodiments, the bone tie 100 canmaintain the anatomical spacing. The bone tie 100 can be a retainingmember for anchoring a prosthesis or implant within the facet joint. Insome embodiments, the bone tie 100 can pass through a central opening ofthe prosthesis or implant when the prosthesis or implant is insertedwithin the facet joint space. The bone tie 100 can be adapted forsecuring the location of the prosthesis or implant with respect to atleast one of the articular surfaces.

The prosthesis or implant can have any shape or configuration. Theprosthesis or implant can be substantially disc shaped. The first sideof the prosthesis or implant can be concave, convex, or flat. The secondside of the prosthesis or implant can be concave, convex, or flat. Theshape can be determined based on a shape of a bone portion that thefirst side and the second side are configured to contact. In someembodiments, the prosthesis or implant fits entirely within the jointdisc space. The prosthesis or implant can include any biocompatiblematerial, e.g., stainless steel, titanium, PEEK, nylon, etc.

The bone tie 100 can have a width of 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm,3 mm, 3.5 mm, 4 mm, or any range of the foregoing values. The width ofthe bone tie 100 can vary along the length of the bone tie 100. The bonetie 100 can have a thickness of 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3mm, 3.5 mm, 4 mm, or any range of the foregoing values. The thickness ofthe bone tie 100 can vary along the length of the bone tie 100. The bonetie 100 can have a length of 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm,70 mm, 80 mm, 90 mm, 100 mm, 110 mm, 120 mm, 130 mm, 140 mm, 150 mm, 160mm, 170 mm, 180 mm, 190 mm, 200 mm, or any range of the foregoingvalues. For example, the bone tie 100 can have a length of 175 mm. Insome embodiments, the second section 110 or the gears 128 can have alength of 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm,50 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, or any range of the foregoingvalues.

The bone tie 100 can be manufactured from any of a variety of materialsknown in the art, including but not limited to a polymer such aspolyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene,fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia,alumina, or silicon nitride; a metal such as titanium, titanium alloy,cobalt chromium or stainless steel; or any combination of the materialsdescribed herein. The bone tie 100 can include any biocompatiblematerial, e.g., stainless steel, titanium, PEEK, nylon, etc. In someembodiments, the bone tie 100 comprises at least two materials. The bonetie 100 can include a reinforcement piece disposed within the bone tie100. By selecting a particular configuration and the one or morematerials for the bone tie 100, the bone tie 100 can be designed to havethe desired flexibility and resiliency.

In some embodiments, the bone tie 100 can form a unitary structure. Thebone tie 100 can be integrally formed from the proximal end 102 to thedistal end 104. In some embodiments, the bone tie 100 can include one ormore unitarily formed sections along the length of the bone tie 100. Oneor more of the fastener section 106, the first section 108, the secondsection 110, the third section 112, the neck section 114, and the headsection 116 can be unitarily formed. In some embodiments, the bone tie100 can include one or more separately formed sections along the lengthof the bone tie 100. One or more of the fastener section 106, the firstsection 108, the second section 110, the third section 112, the necksection 114, and the head section 116 can be separately formed. In someembodiments, the marker 144 is separately formed. In some embodiments,the bone tie 100 can form a monolithic structure. The bone tie 100 canbe monolithically formed or separately formed. The bone tie 100 can beformed of the same or similar material. The sections of the bone tie 100can be formed of the same or similar construction. In some embodiments,the bone tie 100 is formed from an injection molding process.

In some embodiments, the shape of the first section 108, the secondsection 110, and/or the third section 112 can be determined based on theshape of an artificial lumen formed through an articular process of avertebra. In some embodiments, the shape of the artificial lumen iscylindrical, the shape of the head 136 can be rounded or spherical toallow the head 136 to slideably advance through the artificial lumen. Insome embodiments, the shape of the artificial lumen has across-sectional dimension or diameter greater than the cross-sectionaldimension or diameter of the head 136 to allow the head 136 to slideablyadvance through the artificial lumen. The head 136 can have a largercross-sectional dimension or diameter than the first section 108, thesecond section 110, the third section 112, and the neck section 114 toallow the first section 108, the second section 110, the third section112, and the neck section 114 to easily slide within the artificiallumen.

In some embodiments, the characteristic of the bone tie 100 can varyalong the length of the bone tie 100. The characteristics can varybetween one or more of the fastener section 106, the first section 108,the second section 110, the third section 112, the neck section 114, andthe head section 116. In some embodiments, each section has differentcharacteristics. In some embodiments, the flexibility of the bone tie100 varies along the length of the bone tie 100. In some embodiments,the torsional strength of the bone tie 100 varies along the length ofthe bone tie 100. In some embodiments, the resistance to deformation orelongation of the bone tie 100 varies along the length of the bone tie100. In some embodiments, the characteristic of the bone tie 100 varybased, at least in part, on the shape of the various sections.

In some embodiments, the characteristic of the bone tie 100 vary basedon the material of the various sections. In some embodiments, thecharacteristic of the bone tie 100 vary along the length based, at leastin part, on a reinforcement piece. The reinforcement piece can beseparately formed from or integrally formed with the bone tie 100. Thereinforcement piece can comprise a different material or materialproperty. In some embodiments, the reinforcement piece is disposedwithin a section of the bone tie 100. The reinforcement piece can bedisposed within the fastener section 106, the first section 108, thesecond section 110, the third section 112, the neck section 114, thehead section 116, any combination of the foregoing, or disposed onlywithin one or more sections of the foregoing. The reinforcement piececan increase the strength of a section of the bone tie 100. In someembodiments, the reinforcement piece has a substantially uniform shape.The shape, material, or other characteristics of the reinforcement piececan be selected depending on the desired bending and/or torsioncharacteristics of the material chosen. The reinforcement piece canincrease or decrease bending strength. The reinforcement piece canincrease or decrease torsion strength. Any shape, material, or otherproperty of the reinforcement piece can be selected to achieve thedesired bending and/or torsion strength of the bone tie 100. In someembodiments, the reinforcement piece is radiopaque. In some embodiments,the reinforcement piece is radiolucent.

3. Bone Tie Advancer

FIGS. 6-8 depict views of an embodiment of a bone tie advancer 200. FIG.6 illustrates a perspective front view. FIG. 7 illustrates a perspectivefront view of a distal portion. FIG. 8 illustrates a perspective backview of a distal portion. The bone tie advancer 200 can include aproximal end 202 and a distal end 204.

The bone tie advancer 200 can include a proximal handle 206. Theproximal handle 206 can be any shape configured to be gripped by theuser. The proximal handle 206 can include one or more grooves designedto accommodate the fingers of the user. The proximal handle 206 can beshaped for right-handed use, left-handed use, or ambidextrous use. Theproximal handle 206 can include an impact cap 208. The impact cap 208can have a flat proximal end to allow a force to be applied.

The bone tie advancer 200 can include a shaft 210. The shaft 210 canextend distally from the proximal handle 206. The shaft 210 can includean upper portion 212. The upper portion 212 can be cylindrical. Theupper portion 212 can have one or more cylindrical sections of varyingdiameters. The upper portion 212 can include a stepped surface. Theupper portion 212 can have any cross-sectional shape including round,square, rectangular, polygonal, oval, or any other shape. The upperportion 212 can be an elongate member. The upper portion 212 can liealong a longitudinal axis 250.

The shaft 210 can include a tapered portion 214. The tapered portion 214can be distal to the upper portion 212 of the shaft 210. The taperedportion 214 can have a narrower cross-section toward the distal end 204.The tapered portion 214 can be frusto-conical. The tapered portion 214can have a reduced cross-section relative to the upper portion 212 ofthe shaft 210 to enable the shaft 210 to be positioned relative to thepatient's anatomy. The tapered portion 214 can lie along thelongitudinal axis 250. The tapered portion 214 can taper inward relativeto the longitudinal axis 250. The upper portion 212 and the taperedportion 214 can be coaxial.

The shaft 210 can include a curved portion 216. The curved portion 216can be distal to the tapered portion 214 of the shaft 210. The curvedportion 216 can have a substantially constant width. The curved portion216 can have a reduced cross-section relative to the upper portion 212of the shaft 210 to enable the shaft 210 to be positioned relative tothe patient's anatomy. The curved portion 216 can be shaped to beinserted within the artificial lumen of the bone portions. The curvedportion 216 can be shaped according to the lumen-forming tool thatcreates the lumen in the bone portions. The curved portion 216 can havea constant radius of curvature. The curved portion 216 can curve awayfrom the longitudinal axis 250 of the upper portion 212. The curvedportion 216 can extend laterally from the longitudinal axis 250 of theupper portion 212.

FIGS. 7 and 8 are enlarged views of the distal portion of the bone tieadvancer 200. The curved portion 216 can include a rounded surface 218.The rounded surface 218 can extend distally from the tapered portion214. The rounded surface 218 can be proximal-facing. The shaft 210 caninclude a planar surface 220. The planar surface 220 can bedistal-facing. The planar surface 220 can form the outside curve of thecurved portion 216. The rounded surface 218 can form the inside curve ofthe curved portion 216. The planar surface 220 can extend along at leasta portion of the curved portion 216. The planar surface 220 can extendalong at least a portion of the tapered portion 214.

The shaft 210 can include an advancer portion 222. The advancer portion222 can be configured to interface with the bone tie 100. The advancerportion 222 can be located at or near the distal end 204 of the bone tieadvancer 200. The advancer portion 222 can include a curved surface 224.The curved surface 224 can correspond to the curvature of the head 136.The curved surface 224 can cup the head 136. The curved surface 224 cancurve around the distal-facing portion of the head 136. The curvedsurface 224 can allow the force of the bone tie advancer 200 to betransferred to the head 136. The curved surface 224 can allow movementof the bone tie advancer 200 to be transferred to the head 136. Thecurved surface 224 can form the distal end 204 of the bone tie advancer200. The advancer portion 222 can include a tapered surface 226. Thetapered surface 226 can be proximal-facing. The tapered surface 226 canallow visualization and clearance relative to the patient's anatomy. Theadvancer portion 222 can include retaining arms 230. The retaining arms230 can extend proximally from the curved surface 224 and can beseparately formed from or integrally formed with the curved surface 224.The retaining arms 230 can engage the flange 138. The retaining arms 230can engage the second tapered surface 142 of the flange 138. Theretaining arms 230 can engage the neck section 114. The interior portionof the retaining arms 230 can be rounded, tapered, or any other shapecorresponding to the flange 138, second tapered surface 142 and/or necksection 114. The retaining arms 230 can facilitate secure engagement ofthe bone tie 100 for insertion of the bone tie 100 within the artificiallumen of the bone portions.

The advancer portion 222 can include a channel 228. The channel 228 cancorrespond to the shape of the neck section 114 of the bone tie 100. Theneck section 114 of the bone tie 100 can be disposed within the channel228 when the curved surface 224 abuts the head 136. The channel 228 canbe formed by three sides. The three sides can include rounded edges. Thethree sides can have any shape to accept the bone tie 100. The channel228 can include an open side. The open side can be distal-facing. Thechannel 228 can surround a portion of the neck section 114 of the bonetie 100. When the neck section 114 of the bone tie 100 is disposedwithin the channel 228, the curved surface 224 can align and abut thehead 136. The channel 228 can increase the contact between the advancerportion 222 and the bone tie 100.

4. Bone Tie Retriever

FIGS. 9-13 depict views of an embodiment of a bone tie retriever 300.FIG. 9 illustrates a perspective front view. FIG. 10 illustrates aperspective front view of a distal portion. FIG. 11 illustrates a frontview of a distal portion. FIG. 12 illustrates a cross-sectional view ofthe distal portion. FIG. 13 illustrates a cross-sectional view of thedistal portion. The bone tie retriever 300 can include a proximal end302 and a distal end 304.

The bone tie retriever 300 can include a proximal handle 306. Theproximal handle 306 can be any shape configured to be gripped by theuser. The proximal handle 306 can include one or more grooves designedto accommodate the fingers of the user. The proximal handle 306 can beshaped for right-handed use, left-handed use, or ambidextrous use. Theproximal handle 306 can include an impact cap 308. The impact cap 308can have a flat proximal end to allow a force to be applied. Theproximal handles 206, 306 can be the same or similar. The proximalhandles 206, 306 can be mirror images. In some embodiments, the proximalhandle 206 can be designed for use with the right hand of the user andthe proximal handle 306 can be designed for use with the left hand ofthe user. The proximal handles 206, 306 can be different. The proximalhandles 206, 306 can include a different visual indicator to indicatethe different functions of the bone tie advancer 200 and the bone tieretriever 300. In some embodiments, the proximal handles 206, 306 can bedifferent colors or include a visual marking.

The bone tie retriever 300 can include a shaft 310. The shaft 310 canextend distally from the proximal handle 306. The shaft 310 can includean upper portion 312. The upper portion 312 can be cylindrical. Theupper portion 312 can have one or more cylindrical sections of varyingdiameters. The upper portion 312 can include a stepped surface. Theupper portion 312 can have any cross-sectional shape including round,square, rectangular, polygonal, oval, or any other shape. The upperportion 312 can be an elongate member. The upper portion 312 can liealong a longitudinal axis 350. The upper portions 212, 312 can be thesame or substantially similar. The shaft 310 can include a retrieverportion 314. The retriever portion 314 can be distal to the upperportion 312 of the shaft 310.

FIG. 10 illustrates an enlarged view of a distal portion of the bone tieretriever 300. The retriever portion 314 can be shaped to receive thehead 136 of the bone tie 100. The retriever portion 314 can include achannel 316. The channel 316 can include a rounded portion 320. Therounded portion 320 can include a curvature corresponding to the head136 of the bone tie 100. The channel 316 can be concave along thelongitudinal axis 350.

The channel 316 can include a ledge 318. The ledge 318 can be flat,curved, or tapered. The ledge 318 can include a curvature thatcorresponds to the curvature of the head 136. The ledge 318 can bedimensioned to allow for pivotal and/or rotational movement of the head136 within the channel 316. In some embodiments, the ledge 318 can havea curved or poly-axial surface configured to accept the head 136. Insome embodiments, the ledge 318 can be concave. In some embodiments, theledge 318 can have a concavity that corresponds to a convexity of thehead 136. The concavity of the ledge 318 can allow the head 136 to pivotand/or rotate while still retaining the head 136 within the channel 316.The ledge 318 can allow the head 136, and thus the bone tie 100, topivot 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°,130°, 140°, 150°, 160°, 170°, 180°, or any range of the foregoingvalues. In particular embodiments, the ledge 318 can allow the head 136,and thus the bone tie 100, to pivot 60°, 70°, 80°, 90°, or any range ofthe foregoing values. The ledge 318 can allow the head 136 to abut androtate against the ledge 318.

The retriever portion 314 can include an opening 322. The opening 322can be located at or near the distal end 304. The ledge 318 surroundsthe opening 322. The ledge 318 can be shaped to allow the neck section114 to pass through the opening 322. The ledge 318 can be shaped toprevent the head 136 from passing through the opening 322. The ledge 318can be sized according to the corresponding bone tie 100.

The retriever portion 314 can include one or more retention features324. In the illustrated embodiment, the retriever portion 314 includestwo retention features 324. The one or more retention features 324narrow the channel 316 near the distal end 304. The channel 316 extendsthrough the one or more retention features 324. The one or moreretention features 324 can be disposed near the ledge 318. The one ormore retention features 324 can function to retain the head 136 when thehead 136 is seated against the ledge 318.

In some embodiments, the channel 316 may be dimensioned to allow entryof the head 136, or the head 136 and neck section 114, in generally oneparticular orientation. In some embodiments, the channel 316 may bedimensioned to allow entry of the head 136, or the head 136 and necksection 114, in a range of orientations. In some embodiments, thechannel 316 may be dimensioned to allow entry of the head 136 whereinthe neck section 114 is generally perpendicular to the longitudinal axis350 of the shaft 310. In some embodiments, the channel 316 may bedimensioned to allow retention of the head 136 wherein the neck section114 is generally parallel to or coaxial with the longitudinal axis 350.In some embodiments, the channel 316 is configured to allow the necksection 114 to pass between the one or more retention features 324. Insome embodiments, the retriever portion 314 is configured to allow theneck section 114 to pivot, or pivot and rotate, from extending betweenthe one or more retention features 324 to extending into the opening322. In some embodiments, the retriever portion 314 is configured toallow the neck section 114 to pivot, or pivot and rotate, from theopening 322 to the channel 316. In some embodiments, the channel 316 isconfigured to prevent or limit the head 136 from passing between the oneor more retention features 324.

5. Methods of Use

FIGS. 14 and 15 illustrate the bone tie 100, the bone tie advancer 200,and the bone tie retriever 300 in relation to vertebrae during methodsof use. FIGS. 14 and 15 illustrate the bone tie 100, the bone tieadvancer 200, and the bone tie retriever 300. The proximal ends arevisible and the distal ends are disposed within lumens in the vertebrae.FIG. 15 is a close-up view of FIG. 14. FIG. 16 is a cross-sectional viewillustrating a placement of the bone tie 100 and the bone tie retriever300 in relation to the vertebrae.

The bone tie 100 can be configured to stabilize or fuse adjacentvertebrae. The bone tie 100 can be used to fuse a vertebra V1 andvertebra V2 via the inferior articular process IAP1A of vertebra V1 andthe superior articular process SAP2A of vertebra V2. In some methods ofuse, a second bone tie 100 can be used to fuse a vertebra V1 andvertebra V2 via the inferior articular process IAP1B of vertebra V1 andthe superior articular process SAP2B of vertebra V2. In someembodiments, vertebra V1 and vertebra V2 are fused using only one ofbone tie 100. In some embodiments, one bone tie 100 can be used tostabilize vertebra V1 and vertebra V2 via one of the inferior articularprocess IAP1A of vertebra V1 and the superior articular process SAP2A ofvertebra V2, or, via the inferior articular process IAP1B of vertebra V1and the superior articular process SAP2B of vertebra V2. In someembodiments, two bone ties 100 can be used to stabilize vertebra V1 andvertebra V2 via both of the inferior articular process TAPIA of vertebraV1 and the superior articular process SAP2A of vertebra V2, and, theinferior articular process IAP1B of vertebra V1 and the superiorarticular process SAP2B of vertebra V2. The methods described herein canbe repeated for any pair of an inferior articular process and a superiorarticular process.

In some methods of use, a lumen is formed through the articularprocesses. The lumen can be formed with a lumen-forming tool, such as adrill, tissue punch, or reamer. The lumen is formed through one or morearticular processes of the vertebrae to facilitate implantation of thebone tie 100. In some embodiments, at least a portion of the lumen has acurved or non-linear configuration. In some embodiments, at least aportion of the lumen has a straight or linear configuration. In somemethods of use, two or more lumens are formed. A drill or other devicecan be used to form a lumen in superior articular process SAP ofvertebra V2 and inferior articular process IAP of vertebra V1.Specifically, the drill can be used to form the lumen in a facet ofsuperior articular process SAP of vertebra V2 and to form the lumen in afacet of inferior articular process IAP of vertebra V1. In someembodiments, one lumen-forming tool forms one or more lumens. In someembodiments, two lumen-forming tools are utilized to form two lumens.

In some methods of use, a portion of the surface of the facet of SAP andIAP can be prepared for fusion. In some methods of use, a portion of thesurface of the facet can be ground, scored, roughened, or sanded, suchthat the surface of the facet can better adhere to any substances to aidin fusion and/or otherwise fuse more readily to an implant orprosthesis. In some methods of use, the surgical procedure can includepreparing the area near and/or around the vertebra by, for example,removing all or a portion of ligaments, cartilage, and/or other tissue.In some methods of use, the area near and/or around a facet joint can beprepared by removing all or a portion of the facet joint capsule. Theimplant or prosthesis, if provided, can be inserted between the superiorarticular process SAP of vertebra V2 and inferior articular process IAPof vertebra V1.

FIG. 16 illustrates a cross-sectional view of the vertebrae. The bonetie 100, the bone tie advancer 200 (not shown in FIG. 16), and the bonetie retriever 300 can be located within lumens as described herein. Thefirst lumen 400 can be curved. The first lumen 400 can extend from afirst vertebra toward a second vertebra. The first lumen 400 can extendthrough the facet joint space. The second lumen 402 can be straight. Thesecond lumen 402 can extend downward from a surface of the secondvertebra. The second lumen 402 can extend only through the secondvertebra. The second lumen 402 can intersect the first lumen 400.

The bone tie 100 can be positioned within and adjacent to the bone tieadvancer 200. As the bone tie advancer 200 is moved by the user, thehead section 116 and the neck section 114 is correspondingly moved. Thebone tie 100 can be advanced through the first lumen 400 by the bone tieadvancer 200. The bone tie 100 can be advanced through the facet jointspace by the bone tie advancer 200. The bone tie 100 can be advancedthrough at least a portion of the second lumen 402 by the bone tieadvancer 200. In some embodiments, the bone tie 100 and the bone tieadvancer 200 can have a bend or curve to facilitate directing the head136 of the bone tie 100 into the lumen 400. In some embodiments, thebone tie 100 and the bone tie advancer 200 can have a bend or curvecorresponding to the curvature of the first lumen 400. The bone tie 100and the bone tie advancer 200 can have any shape that allows the passagethrough the first lumen 400 and into the second lumen 402.

The bone tie 100 is advanced until the head 136 of bone tie 100 ispositioned near the bone tie retriever 300. The bone tie 100 is advanceduntil the head 136 of bone tie 100 is inserted into the channel 316. Thebone tie 100 and the bone tie advancer 200 can have any shape thatallows the passage of the head 136 into the channel 316. The bone tie100 can be advanced until the head 136 abuts the inside wall of theretriever portion 314. The bone tie 100 can be advanced until anyfurther advancement is prevented by the retriever portion 314.

During advancement, the head 136 of the bone tie 100 can be monitoredunder radiographic visualization. The head 136 can include one or moremarkers 144. In the illustrated embodiment, the head 136 can include abore 146 configured to receive the marker 144. The marker 144 canfacilitate visualization of the head 136 because the marker 144 can beradiopaque. The marker 144 can facilitate placement of the head 136relative to the lumens 400, 402. The marker 144 can facilitate placementof the head 136 relative to the retriever portion 314.

FIGS. 17-18 illustrate the bone tie 100, the bone tie advancer 200, andthe bone tie retriever 300 during methods of use. FIG. 17 is a side viewof the bone tie 100, the bone tie advancer 200, and the bone tieretriever 300. FIG. 18 is a perspective view of the bone tie 100, thebone tie advancer 200, and the bone tie retriever 300.

The bone tie 100 can be coupled to the bone tie advancer 200. FIG. 17illustrates the bone tie 100 coupled to the bone tie advancer 200. FIG.18 is an enlarged view of the distal portion. The bone tie 100 caninclude the neck section 114 and the head section 116. The bone tieadvancer 200 can include the advancer portion 222. The advancer portion222 can couple to the head section 116 of the bone tie 100. The advancerportion 222 can couple to the head 136 of the bone tie 100. The advancerportion 222 can include a curved surface 224 that can grasp the head136. The advancer portion 222 can couple to the neck section 114 of thebone tie 100. The advancer portion 222 can include a channel 228 thatcan grasp a portion of the neck section 114. The advancer portion 222can couple to the bone tie 100 prior to insertion of the bone tie 100,or after bone tie 100 has been inserted, into a lumen in a bone portion.The movement of the bone tie advancer 200 can cause movement of the bonetie 100.

The bone tie advancer 200 can move the head 136 of the bone tie 100toward the bone tie retriever 300. The retriever portion 314 can includethe channel 316. The channel 316 can be concave along the longitudinalaxis 350 of the shaft 310. The channel 316 can be shaped to receive thehead 136 of the bone tie 100. The head 136 can be inserted proximal tothe one or more retention features 324. The head 136 can be insertedalong the length of the channel 316. The head 136 can be insertedproximal to the ledge 318. The head 136 can be inserted proximal to theopening 322.

The head 136 enters the channel 316 when advanced by the bone tieadvancer 200. The neck section 114 enters the channel 316 when advancedby the bone tie advancer 200. In some methods of use, the bone tieadvancer 200 enters the channel 316. In some methods of use, the bonetie advancer 200 does not enter the channel 316.

The bone tie advancer 200 can be used to advance the bone tie 100through the first lumen 400. The first lumen 400 can be curved. The bonetie advancer 200 can include the curved portion 216. The curved portion216 can have the same or similar curvatures as the curved lumen 400. Thecurved lumen 400 can be formed in the bone to allow passage of the bonetie advancer 200. The user manipulates the proximal handle 206 to alignthe advancer portion 222 with the opening of the first lumen 400. Theuser can pivot and/or rotate and translate the bone tie advancer 200 tomove the bone tie advancer 200 and the bone tie 100 through the firstvertebra V1. The user can pivot and/or rotate and translate the bone tieadvancer 200 to move the bone tie advancer 200 and the bone tie 100through the facet joint space. The user can pivot and/or rotate andtranslate the bone tie advancer 200 to move the bone tie advancer 200and the bone tie 100 into the second vertebra V2.

The bone tie retriever 300 can be inserted into the second lumen 402.The second lumen 402 can be generally straight. The second lumen 402 canextend distally beyond the first lumen 400. The second lumen 402 canextend to a depth to allow the channel 316 of the bone tie retriever 300to align with the first lumen 400 when the bone tie retriever 300 iswithin the second lumen 402. The second lumen 402 can be any size ordepth in order to accommodate the retriever portion 314 therewithin. Theretriever portion 314 can be positioned within the second lumen 402 suchthat when the head section 116 is advanced from the first lumen 400, thehead section 116 is inserted along the length of the channel 316. Insome embodiments, the retriever portion 314 can be positioned within thesecond lumen 402 such that when the head section 116 is advanced fromthe first lumen 400, the head section 116, or the head section 116 andat least a portion of the neck section 114, is inserted along the lengthof the channel 316. The retriever portion 314 can be positioned suchthat the head 136 is inserted proximal to the one or more retentionfeatures 324. In some embodiments, the distal end 304 of the bone tieretriever 300 can be recessed below the first lumen 400 when the bonetie retriever 300 is received within the second lumen 402.

FIGS. 19-21 illustrate the bone tie 100 and the bone tie retriever 300during methods of use. FIG. 19 is a perspective view of the bone tie 100and the bone tie retriever 300 in a first orientation. FIG. 20 is aperspective view of the bone tie 100 and the bone tie retriever 300 in asecond orientation. FIG. 21 is a distal view of the bone tie 100 and thebone tie retriever 300 in the second orientation.

FIG. 19 is a perspective view of the bone tie 100 and the bone tieretriever 300 in a first orientation. In some methods of use, the head136 of the bone tie 100 is inserted into the bone tie retriever 300 ingenerally one particular orientation. In some methods of use, the necksection 114 of the bone tie 100 is perpendicular to the longitudinalaxis 350 of the bone tie retriever 300 when the bone tie 100 is insertedinto the bone tie retriever 300. In some methods of use, the head 136 ofthe bone tie 100 is inserted into the bone tie retriever 300 in a rangeof orientations. In some methods of use, the neck section 114 of thebone tie 100 is generally skewed to the longitudinal axis 350 of thebone tie retriever 300 when the bone tie 100 is inserted into the bonetie retriever 300. In some methods of use, the neck section 114 of thebone tie 100 can be any angle to the longitudinal axis 350 of the bonetie retriever 300 including 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°,100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range ofthe foregoing values. In particular methods of use, the neck section 114of the bone tie 100 can be any angle to the longitudinal axis 350 of thebone tie retriever 300 including 60°, 70°, 80°, 90°, 100°, 110°, 120°,or any range of the foregoing values.

FIG. 20 is a perspective view of the bone tie 100 and the bone tieretriever 300 in a second orientation. FIG. 21 is a distal view of thebone tie 100 and the bone tie retriever 300 in the second orientation.In some methods of use, the neck section 114 of the bone tie 100 isgenerally aligned with the longitudinal axis 350 of the bone tieretriever 300 when the bone tie 100 is pivoted. In some methods of use,the neck section 114 of the bone tie 100 can be any angle to thelongitudinal axis 350 of the bone tie retriever 300 including 0°, 5°,10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, or any range ofthe foregoing values.

In some methods of use, the head 136 of the bone tie 100 is configuredto slide within the channel 316. In some methods of use, the head 136slides distally within the channel 316. The channel 316 can include theledge 318. The ledge 318 can include a curvature that corresponds to thecurvature of the head 136. The ledge 318 can be dimensioned to allow forpivotal and/or rotational movement of the head 136 within the channel316. In some embodiments, the ledge 318 can have a curved or poly-axialsurface configured to accept the head 136. In some embodiments, theledge 318 can be concave. In some embodiments, the ledge 318 can have aconcavity that corresponds to a convexity of the head 136. The ledge 318can allow the head 136 to abut and rotate against the ledge 318. The oneor more retention features 324 can allow the head 136 to be seated androtate within the distal portion of the bone tie retriever 300. As thehead 136 slides distally, the neck section 114 slides between the one ormore retention features 324.

The concavity of the ledge 318 can allow the head 136 to pivot and/orrotate while still retaining the head 136 within the channel 316. Theledge 318 can allow the head 136, and thus the bone tie 100, to pivotand/or rotate. In some methods of use, the bone tie 100 can pivotapproximately 90°. In some methods of use, the bone tie 100 pivots 30°,40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, or anyrange of the foregoing values.

In some embodiments, the channel 316 may be dimensioned to allowretention of the head 136 when the neck section 114 is generallyparallel or coaxial to the longitudinal axis 350 of the shaft 310. Insome embodiments, the channel 316 is configured to allow the necksection 114 to pass between the one or more retention features 324. Insome embodiments, the retriever portion 314 is configured to allow theneck section 114 to pivot, or pivot and rotate, from extending betweenthe one or more retention features 324 into the opening 322. The opening322 can be located at or near the distal end 304. The ledge 318surrounds the opening 322. The ledge 318 can be shaped to support thehead 136 when the bone tie 100 is pivoted and/or rotated. The ledge 318and/or the one or more retention features 324 can be shaped to constrainthe head 136 when the bone tie 100 is pivoted and/or rotated.

The bone tie 100 can be retracted by the bone tie retriever 300. Thebone tie retriever 300 can be pulled distally from the second lumen 402.The neck section 114 can pivot and/or rotate to extend distally from thebone tie retriever 300 as the bone tie 100 is pulled proximally. The oneor more retention features 324 can limit or prevent lateral movement ofthe head 136 when the bone tie is in the second orientation relative tothe bone tie retriever 300. The one or more retention features 324 canfacilitate retention of the head 136 within the channel 316. The bonetie retriever 300 can pull the bone tie 100 through the second lumen402. The bone tie retriever 300 can pull the bone tie 100 until thedistal end 104 of the bone tie 100 is outside of the lumen 402.

In some methods of use, the proximal end 102 and the distal end 104 canbe outside of the vertebrae after use of the bone tie advancer 200 andbone tie retriever 300. The bone tie 100 can form a curved shape. Insome methods of use, a portion of the second section 110 can be disposedwithin the lumens 400, 402. In some methods of use, a portion of thethird section 112 can be disposed within the lumens 400, 402. In somemethods of use, a portion of the second section 110 and a portion of thethird section 112 can be disposed within the lumens 400, 402 when theproximal end 102 and the distal end 104 are outside of the vertebrae.

In some methods of use, the head section 116 can be removed. The bonetie 100 can be cut or severed near the neck section 114. The bone tie100 can be cut or severed to remove the head section 116. The bone tie100 can be cut or severed to remove the head section 116 and a portionof the neck section 114. The head section 116 can be discarded. The headsection 116 and a portion of the neck section 114 can be discarded. Theneck section 114 can be advanced through the lumen 118 of the fastenersection 106. While the neck 114 is being advanced, the ratchet 122 canextend into the groove 132. The third section 112 can be advancedthrough the lumen 118. While the third section 112 is being advanced,the ratchet 122 can extend into the groove 130. The second section 110can be advanced through the lumen 118. While the second section 110 isbeing advanced, the ratchet 122 can extend into the groove 126. Theratchet 122 can engage the one or more gears 128. The ratchet 122 canallow the second section 110 to travel through the lumen 118 in onedirection, but limit or prevent travel in the opposite direction.

The bone tie 100 can form a loop. The fastener section 106 can besecured to the second section 110. Securing the fastener section 106 canbe based on the type of fastener member used. By way of example,securing the fastener section 106 can include inserting the opposite endof the bone tie 100 into the lumen 118 of the fastener section 106, andadvancing the opposite end through the fastener section 106. Thefastener section 106 can engage the one or more gears 128 of the secondsection 110. The one or more gears 128 can be shaped to allow each gear128 to displace the ratchet 122 of fastener section 106 in only onedirection.

After the bone tie 100 is secured, superior articular process SAP ofvertebra V2 can fuse to inferior articular process IAP of vertebra V1.Fusing can include one or more of bone material from superior articularprocess SAP of vertebra V2, bone material from inferior articularprocess IAP of vertebra V1, and/or the implant or prosthesis that fusesarticular process SAP of vertebra V2 to inferior articular process IAPof vertebra V1. In some embodiments, after superior articular processSAP of vertebra V2 is fused to inferior articular process IAP ofvertebra V1, the bone tie 100 is not removed. In some embodiments, aftersuperior articular process SAP of vertebra V2 is fused to inferiorarticular process IAP of vertebra V1, all or a portion of the bone tie100 can be removed. In some embodiments, the bone tie 100 can be removedafter fusion of superior articular process SAP of vertebra V2 toinferior articular process IAP of vertebra V1 has started, but has notfinished. In some embodiments, the bone tie 100 may comprise abioabsorbable or bioresorbable material.

In use, the bone tie 100 can be configured to stabilize a first vertebraand/or a second vertebra by securing an articular process of the firstvertebra to an articular process of a second vertebra. Morespecifically, the bone tie 100 can be configured to stabilize the firstvertebra and/or a second vertebra by securing an articular process ofthe first vertebra to an articular process of a second vertebra. Thebone tie 100 can be placed into a suitable position relative to thefirst vertebra and/or the second vertebra, and a distal portion of thebone tie 100 can be inserted into the lumen of the fastener section 106.The bone tie 100 can be configured to substantially encircle at least aportion of the first vertebra and the second vertebra. In some methodsof use, the bone tie 100 forms a loop about the articular process of thefirst vertebra and the articular process of the second vertebra. In somemethods of use, the neck section 114 and the third section 112 can beadvanced through the fastener section 106 such that the area disposedwithin the loop formed by the bone tie 100 is reduced.

As the bone tie 100 is tightened, the bone tie 100 exerts a compressiveforce on the articular process of the first vertebra and the articularprocess of the second vertebra. In some methods of use, the implant orprosthesis can be disposed between the articular process of the firstvertebra and the articular process of the second process such that adesired distance between the articular process of the first vertebra andthe articular process of the second process is maintained. The implantor prosthesis can be retained within a loop or other defined segment ofthe bone tie 100. In some methods of use, the excess portion of thesecond section 110 and/or the third section 112 can be removed once thebone tie 100 is tightened. In some embodiments, the excess portion ofthe bone tie 100 can be removed from the space around the vertebrae. Theexcess portion of the bone tie 100 can be removed by cutting or breakingthe excess portion of the bone tie 100. The excess portion can beremoved without loosening or removing the loop formed by the bone tie100 around the first vertebra and the second vertebra.

In some embodiments described herein, the bone tie 100 can be used tostabilize and/or fixate a first vertebra to a second vertebra. The bonetie 100 can be configured to reduce pain associated with a bone portion.The bone tie 100 can be configured to reduce further degradation of aspine. The bone tie 100 can be configured to reduce further degradationof a specific vertebra of a spine. The bone tie 100 can be configured toreduce movement until the first vertebra and the second vertebra havefused. The bone tie 100 can be configured to stabilize the firstvertebra and second vertebra by securing an articular process of thefirst vertebra to an articular process of a second vertebra.

6. Bone Tie Retriever

FIGS. 22-27 depict views of an embodiment of a bone tie retriever 500.The bone tie retriever 500 can have any of the features of the bone tieretriever 300 described herein. The bone tie retriever 500 can be usedin any method described herein. The bone tie retriever 500 can include acatcher mechanism 530 as described herein. FIG. 22 illustrates aperspective view of the bone tie retriever 500. FIG. 23 illustrates aperspective view of a distal portion of the bone tie retriever 500 withthe catcher mechanism 530 in a retracted or neutral position. FIG. 24illustrates a front view of a distal portion of the bone tie retriever500 with the catcher mechanism 530 in the retracted or neutral position.FIG. 25 illustrates a front view of a distal portion of the bone tieretriever 500 with the catcher mechanism 530 in an advanced position.FIG. 26 illustrates a cross-sectional view of the distal portion of thebone tie retriever 500. FIG. 27 illustrates another cross-sectional viewof the distal portion of the bone tie retriever 500.

Referring to FIG. 22, the bone tie retriever 500 can include a proximalend 502 and a distal end 504. The bone tie retriever 500 can include aproximal handle 506 to be gripped by the user. The bone tie retriever500 can be configured to be gripped by one hand of the user. The usercan grip the bone tie advancer 200 with the other hand. The bone tieretriever 500 can be configured for one handed operation. The bone tieretriever 500 can be configured for left-hand use. The bone tieretriever 500 can be configured for right-hand use. The bone tieretriever 500 can be configured for ambidextrous use. The proximalhandles 206, 306, 506 can include a different visual indicator toindicate the different functions of the bone tie advancer 200 and thebone tie retriever 300, 500.

The bone tie retriever 500 can include a shaft 510. The shaft 510 canextend distally from the proximal handle 506. The shaft 510 can includean upper portion 512. The upper portion 512 can be external to thepatient during use. The shaft 510 can include a retriever portion 514.The retriever portion 514 can be configured to be inserted into apatient. In some methods of use, the retriever portion 514 is configuredto be inserted into a lumen in a pedicle. In some methods of use, theretriever portion 514 is visibly obscured during use. The retrieverportion 514 can be distal to the upper portion 512. The bone tieretriever 500 can have a longitudinal axis 550. The longitudinal axis550 can extend through the proximal handle 506 and the shaft 510.

FIGS. 23-27 illustrate a distal portion of the bone tie retriever 500.The retriever portion 514 can include a channel 516. The channel 516 canextend along a portion of the longitudinal axis 550. The channel 516 canbe shaped to receive the head 136 of the bone tie 100. In some methodsof use, the bone tie advancer 200 advances the head 136 of the bone tie100 into the channel 516. In some methods of use, the bone tie advancer200 advances the head 136 of the bone tie 100 when the retriever portion514 is visibly obscured.

The channel 516 can be shaped to receive the head 136 of the bone tie100. The channel 516 can include a central lumen. The central lumen ofthe channel 516 can extend through the retriever portion 514. Thecentral lumen of the channel 516 can be coaxial with the longitudinalaxis 550. The channel 516 can include a lateral opening. The lateralopening of the channel 516 can extend along a portion of thecircumference of the retriever portion 514. In some embodiments, thelateral opening of the channel 516 can extend approximately 120 degreesof the circumference of the retriever portion 514. Other ranges arecontemplated including 90 degrees, 105 degrees, 135 degrees, 150degrees, 165 degrees, 180 degrees, or any range of two of the foregoingvalues.

The lateral opening of the channel 516 can be shaped to receive the head136 of the bone tie 100. In some embodiments, the proximal end of thelateral opening of the channel 516 can include a rounded portion 520. Insome embodiments, the distal end of the lateral opening of channel 516can be rounded. The retriever portion 514 can include one or moreretention features 524 to facilitate retention of the head 136 of thebone tie 100. The one or more retention features 524 can be protrusionsthat function to retain the head 136 within the channel 516. The one ormore retention features 524 can be rounded. The one or more retentionfeatures 524 can form a portion of the lateral opening. The one or moreretention features 524 can form a border of the lateral opening. Thespace between two retention features 524 can form a portion of thelateral opening. The space between two retention features 524 can form aborder of the lateral opening.

The central lumen of the channel 516 can be shaped to receive the head136 of the bone tie 100. The distal end of the channel 516 can include aledge 518. The ledge 518 can correspond to the curvature of the head136. The ledge 518 can be complementary to the curvature of the head136. The ledge 518 can be dimensioned to allow for pivotal and/orrotational movement of the head 136 within the retriever 500. Thecentral lumen can include an opening 522. The opening 522 can allow aportion of the bone tie 100 to extend distally from the bone tieretriever 500. The body of the bone tie 100 can rotate from a positionbetween two retention features 524 to a position within the opening 522.The body of the bone tie 100 can rotate from the lateral opening of thechannel 516 to a position within the opening 522.

The bone tie retriever 500 can include the catcher mechanism 530. Thecatcher mechanism 530 is configured to capture the head 136 of the bonetie 100. The catcher mechanism 530 is configured to facilitate retentionof the head 136 of the bone tie 100 within the channel 516. The catchermechanism 530 can function in combination with the one or more retentionfeatures 524 to facilitate retention of the head 136 of the bone tie100.

The catcher mechanism 530 can be shaped to slide within the channel 516.The catcher mechanism 530 can include a catch 532. The catcher mechanism530 can include an alignment block 534. The catch 532 and the alignmentblock 534 can be monolithically or integrally formed. The catch 532 andthe alignment block 534 can be separately formed.

The catch 532 can be configured to slide within the lateral opening ofthe channel 516. The catch 532 can extend distally from the alignmentblock 534. The catch 532 can include a rounded distal end. The catch 532can include a concave end. The catch 532 can include a convex end. Thecatch 532 can include a radius of curvature. The catch 532 can include aradius of curvature to correspond to the curvature of the head 136. Thecatch 532 can include a radius of curvature to be complementary to thecurvature of the head 136. The catch 532 is configured to slide downrelative to the channel 516. The catch 532 can be sized to cover aportion of the lateral opening of the channel 516. The catch 532 can bepositioned distal to the rounded portion 520 of the channel 516. Thecatch 532 can be positioned proximal to the one or more retentionfeatures 524.

The alignment block 534 can be configured to slide within the centrallumen of the channel 516. The alignment block 534 can have acomplementary shape to the central lumen of the channel 516. Thealignment block 534 can limit or prevent unwanted movement as thecatcher mechanism 530 slides. The alignment block 534 can include one ormore alignment features. The one or more alignment features can includeone or more pins 536 and one or more grooves 538. The one or morealignment features can include any other feature to facilitate sliding.The one or more alignment features 536, 538 can facilitate the slidingof the catcher mechanism 530 along a linear path. The one or morealignment features 536, 538 can facilitate sliding of the catchermechanism 530 relative to the channel 516. While two grooves 538 areshown, any number of grooves can be provided. While two pins 536 areshown, any number of pins can be provided.

In some methods of use, the catch 532 and the alignment block 534 areshaped to retain the head 136 of the bone tie 100. The head 136 of thebone tie 100 can be retained within the central lumen of the channel116. The head 136 of the bone tie 100 is retained within the void behindthe catch 532. In some embodiments, the head 136 of the bone tie 100does not contact the alignment block 534 during use.

The catcher mechanism 530 can slide between a retracted position shownin FIGS. 22-24 and an advanced position shown in FIG. 25. The catchermechanism 530 can have controlled movement between these two positions.In some embodiments, the catcher mechanism 530 is passively slid betweenpositions, such as under the influence of gravity. In some embodiments,the catcher mechanism 530 is actively slid between positions. In someembodiments, the catcher mechanism 530 is actuated when in the advancedposition.

The catcher mechanism 530 can include an actuator 540 shown in FIG. 22.The actuator 540 can be a button. The actuator 540 is configured to bedepressed by the user. As described herein, the proximal handle 506 isconfigured to be gripped by the user. The fingers of the user can wraparound the proximal handle 506 allowing the thumb of the user toactivate the actuator 540. The actuator 540 is configured to slide thecatcher mechanism 530 distally when the actuator 540 is depressed.

In some embodiments, the actuator 540 can be configured to bottom outwhen the catcher mechanism 530 is slid to the advanced position. In someembodiments, the actuator 540 provides tactile feedback to indicate thatthe catcher mechanism 530 is fully advanced. In some embodiments, thecatcher mechanism 530 can be configured to slide along a continuum ofpositions. In other embodiments, the catcher mechanism 530 has aplurality of discrete positions. The catcher mechanism 530 can includethe advanced position and the retracted position. The catcher mechanism530 can include one or more intermediate positions between the advancedposition and the retracted position. The catcher mechanism 530 can slidesmoothly between positions. The catcher mechanism 530 can have ratchetedsteps between positions.

In some embodiments, the actuator 540 is biased. The actuator 540 caninclude a spring to bias the actuator 540 to a neutral position. In someembodiments, the neutral position can be the retracted position of thecatcher mechanism 530. In some methods, the head 136 of the bone tie 130can be positioned within the channel 516. The user can overcome thebiasing force of the actuator 540 by depressing the actuator 540. Theuser can depress the actuator 540 to slide the catcher mechanism 530distally. The user can retain the head 136 of the bone tie 130 when theactuator 540 is depressed. The catch 532 can prevent the inadvertentrelease of the head 136 of the bone tie 130 when the actuator 540 isdepressed. The user can continue to depress the actuator 540 to retainthe head 136 while the retriever 500 is withdrawn. The user can continueto depress the actuator 540 as the retriever 500 is removed from thebody of the patient. The user can release the actuator 540 once theretriever is withdrawn. The biasing force of the spring can slide thecatcher mechanism 530 to the retracted position. The user can remove thehead 136 of the bone tie 100 from the retriever 500.

In other embodiments, the neutral position can be the advanced position.The user can slide the catcher mechanism 530 proximally to the retractedposition with an actuator. The user can capture the head 136 of the bonetie 130 when the catcher mechanism 530 is retracted. The head 136 of thebone tie 130 can be positioned within the channel 516. The user canrelease the catcher mechanism 530 to return to the neutral position. Thebiasing force of a spring can slide the catcher mechanism 530 to theadvanced position. The user can retain the head 136 of the bone tie 130.The catch 532 can prevent the inadvertent release of the head 136 of thebone tie 130 when the actuator 540 is released. The retriever 500 can beremoved from the body of the patient. The catcher mechanism 530 caninclude any actuator to switch between the retracted and the advancedpositions. The catcher mechanism 530 can include any active or passiveactuator. The advanced position or the retracted position can be theneutral position.

The lateral opening of the channel 516 may be dimensioned to allow entryof the head 136, or the head 136 and neck section 114 when the catch 532is in the retracted position. The bone tie 100 can be perpendicular tothe longitudinal axis 550 of the bone tie retriever 500 during capture.The bone tie 100 can be skewed to the longitudinal axis 550 of the bonetie retriever 500 during capture. The bone tie 100 can be any non-zeroangle relative to the longitudinal axis 550 of the bone tie retriever500 during capture. In some embodiments, the channel 516 may bedimensioned to allow entry of the head 136, or the head 136 and necksection 114, in a range of orientations when the catch 532 is in theretracted position. In some methods, the bone tie 100 can extendlaterally from the bone tie retriever 500 as the bone tie 100 is beinginserted into the channel 516. In some methods, the bone tie 100 can beskewed relative to the longitudinal axis 550 during capture.

Once the head 136 is within the channel 516 of the bone tie retriever500, the bone tie 100 can be retained. The catcher mechanism 530 canslide distally to the advanced position as shown in FIG. 25. The catchermechanism 530 can limit or prevent exit of the head 136, or the head 136and neck section 114 when the catch 532 is in the advanced position. Thecatcher mechanism 530 can retain the head 136 of the bone tie when sliddistally. The bone tie retriever 500 can be removed from the body of thepatient. The bone tie retriever 500 can be pulled from a lumen in apedicle.

The bone tie 100 can pivot and/or rotate as the bone tie retriever 500is retracted. The neck section 114 of the bone tie 100 can pivot and/orrotate between the one or more retention features 524. The neck section114 of the bone tie 100 can pivot distally. The neck section 114 of thebone tie 100 can rotate within the central lumen of the channel 516. Theneck section 114 of the bone tie 100 can pivot to extend distally fromthe bone tie retriever 500. In some embodiments, the neck section 114can pivot and/or rotate from extending between two retention features524 to extending into the opening 522. The catcher mechanism 530 canretain the head 136 of the bone tie 100 during this pivoting and/orrotating movement of the bone tie 100. In some methods, the bone tie 100can extend distally from the bone tie retriever 500 as the bone tie 100is being pulled by the bone tie retriever 500. In some methods, the bonetie 100 can be coaxial with the longitudinal axis 550 during retrieval.

In some embodiments, the bone tie retriever 500 can include an activecatcher mechanism 530. The catcher mechanism 530 will slide down andcapture the head 136 of the bone tie 100 only when the actuator 540 isdepressed. The user actively overcomes the biasing force of the springto slide the catcher mechanism 530. In some embodiments, the bone tieretriever 500 can include a passive mechanism to retain the head 136 ofthe bone tie 100.

The bone tie retriever 500 can include any catcher mechanism that movesto block a portion of the channel 516. In some embodiments, the bone tieretriever 500 can include the catcher mechanism 530 that slides in aproximal and distal direction. In some embodiments, the bone tieretriever 500 can include the catcher mechanism 530 that provides thecatch 532 to limit movement of the head 136 of the bone tie 100. In someembodiments, the bone tie retriever 500 can include the catchermechanism 530 that translates without rotation. In some embodiments, thebone tie retriever 500 can include a catcher mechanism 530 that rotates.In some embodiments, the bone tie retriever 500 can include a catchermechanism 530 that rotates without translation. In some embodiments, thebone tie retriever 500 can include a catcher mechanism 530 that rotatesto at least partially cover the channel 516. In some embodiments, thebone tie retriever 500 can include a catcher mechanism 530 that rotates90 degrees, 120 degrees, 150 degrees, 180 degrees, or any range of theforegoing values. The bone tie retriever 500 can include any catchermechanism 530 that can limit or prevent the release of the head 136 ofthe bone tie 100.

The catcher mechanism 530 can advantageously improve surgical outcomesby consistently retaining the head 136 of the bone tie 100. The catchermechanism 530 can ensure that the bone tie retriever 500 retrieves thehead 136 of the bone tie 100 on the first attempt. The catcher mechanism530 can ensure that the bone tie retriever 500 functions in a consistentand repeatable manner. The catcher mechanism 530 can advantageouslyimprove retention of the head 136 of the bone tie 100. The catch 532 canfunction as a gate preventing the exit of the head 136 of the bone tie100 from the channel 516. The catcher mechanism 530 can advantageouslyimprove reliability and repeatability of the use of the bone tieretriever 500. The catcher mechanism 530 can advantageously improve theuser experience.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while several variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. It should be understood that various featuresand aspects of the disclosed embodiments can be combined with, orsubstituted for, one another in order to form varying modes of thedisclosed invention. For all the embodiments described above, the stepsof the methods need not be performed sequentially. Thus, it is intendedthat the scope of the present invention herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

What is claimed is:
 1. A bone tie inserter for placing a bone tie fortreating the spine, comprising: a bone tie advancer comprising: a shaft;and an advancer portion comprising a curved surface configured to guidea rounded head of a bone tie; a bone tie retriever comprising: a shaft;a retriever portion configured to receive the rounded head of a bonetie, wherein the rounded head of the bone tie is configured to pivotand/or rotate within the retriever portion; and a catcher mechanismconfigured to facilitate retention of the rounded head of the bone tiewithin the retriever portion, wherein the catcher mechanism includes oneor more alignment features, wherein the one or more alignment featurescomprise a pin and a groove.
 2. The bone tie inserter of claim 1,wherein the catcher mechanism includes a catch.
 3. The bone tie inserterof claim 1, wherein the catcher mechanism includes an alignment block.4. The bone tie inserter of claim 1, wherein the catcher mechanismincludes an actuator.
 5. The bone tie inserter of claim 1, furthercomprising the bone tie.
 6. The bone tie inserter of claim 5, whereinthe bone tie is configured to pivot, or pivot and rotate, from extendinglaterally from the bone tie retriever to extending distally from thebone tie retriever.
 7. The bone tie inserter of claim 1, wherein theretriever portion comprises a ledge.
 8. The bone tie inserter of claim1, wherein the retriever portion comprises a channel.
 9. The bone tieinserter of claim 1, wherein the bone tie retriever comprises one ormore retention features configured to retain the bone tie.
 10. The bonetie inserter of claim 1, wherein the one or more alignment featuresfacilitate sliding the catcher mechanism.
 11. The bone tie inserter ofclaim 1, wherein the one or more alignment features facilitate slidingalong a linear path.
 12. A method of treating bone portions, the methodcomprising: advancing a rounded head of a bone tie with a bone tieadvancer, wherein the bone tie advancer is removably coupled to therounded head or a neck section extending from the rounded head;advancing the rounded head of the bone tie into a retriever portion of abone tie retriever, the retriever portion comprising a channel toreceive the rounded head; actuating a catcher mechanism to facilitateretention of the rounded head of the bone tie within the retrieverportion, wherein actuating the catcher mechanism comprises sliding acatch distally; and withdrawing the bone tie retriever.
 13. The methodof claim 12, further comprising forming a lumen in a first bone portion.14. The method of claim 13, further comprising advancing the roundedhead of the bone tie through the lumen of the first bone portion. 15.The method of claim 13, further comprising forming a lumen in a secondbone portion.
 16. The method of claim 15, further comprising withdrawingthe bone tie retriever from the second bone portion.
 17. The method ofclaim 16, wherein the bone tie is configured to pivot and/or rotate asthe bone tie retriever is withdrawn.
 18. The method of claim 12, whereinthe catch slides distally when an actuator is depressed.
 19. The methodof claim 12, wherein a pin slides within a groove as the catch slidesdistally.
 20. The method of claim 12, wherein actuating the catchermechanism comprises overcoming a biasing force.
 21. The method of claim12, wherein the catch prevents the release of the head of the bone tiewhile withdrawing the bone tie retriever.
 22. The method of claim 12,wherein actuating the catcher mechanism comprises sliding the catchalong a linear path.
 23. The method of claim 12, wherein actuating thecatcher mechanism comprises sliding the catch relative to the channel.24. A method of treating bone portions, the method comprising: advancinga rounded head of a bone tie with a bone tie advancer, wherein the bonetie advancer is removably coupled to the rounded head or a neck sectionextending from the rounded head; advancing the rounded head of the bonetie into a retriever portion of a bone tie retriever, the retrieverportion comprising a channel to receive the rounded head; actuating acatcher mechanism to facilitate retention of the rounded head of thebone tie within the retriever portion, wherein actuating the catchermechanism comprises actively depressing an actuator to retain therounded head of the bone tie; and withdrawing the bone tie retriever.25. The method of claim 24, wherein depressing the actuator slides thecatcher mechanism distally.
 26. The method of claim 24, whereinwithdrawing the bone tie retriever comprises withdrawing the bone tieretriever while depressing the actuator.
 27. The method of claim 24,wherein actively depressing the actuator comprises overcoming a biasingforce.
 28. A method of treating bone portions, the method comprising:advancing a rounded head of a bone tie with a bone tie advancer, whereinthe bone tie advancer is removably coupled to the rounded head or a necksection extending from the rounded head; advancing the rounded head ofthe bone tie into a retriever portion of a bone tie retriever, theretriever portion comprising a channel to receive the rounded head;actuating a catcher mechanism to facilitate retention of the roundedhead of the bone tie within the retriever portion, wherein actuating thecatcher mechanism comprises overcoming a biasing force; and withdrawingthe bone tie retriever.
 29. The method of claim 28, wherein the biasingforce slides the catcher mechanism proximally.
 30. The method of claim28, wherein actuating the catcher mechanism slides the catcher mechanismdistally.